Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm

Phase 3 Completed 1004 enrolled Neurana Pharmaceuticals, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a double-blind, randomized, placebo-controlled, multicenter study of the efficacy and safety of tolperisone (a non-opioid) or placebo administered in subjects with pain due to acute back muscle spasm.

Timeline

Start: 2020-12-15
Primary completion: 2021-12-13
Completion: 2022-03-21

Publications

Vaughan SA, Torres K, Kaye R. RESUME-1: a Phase III study of tolperisone in the treatment of painful, acute muscle spasms of the back. Pain Manag. 2022 Jan;12(1):25-33. doi: 10.2217/pmt-2021-0041. Epub 2021 Jul 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tolperisone	Small molecule	50 mg	Oral
Subject	Tolperisone	Small molecule	100 mg	Oral
Subject	Tolperisone	Small molecule	200 mg	Oral

Indications

No indication recorded.